Medical Device Registration and Approval in Indonesia

General country-specific regulatory information is provided on this page for medical device registration and approval in Indonesia. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Indonesia, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Indonesia

REGULATORY AUTHORITY: Ministry of Health (MoH)

CLASSIFICATION SYSTEM: Medical Devices/IVDs: Class A/B/C/D or 1/2/3

TIMEFRAME:

Medical Devices/IVDs – Official Timeline:

Class A – 45 working days

Class B/C – 60 working days

Class D – 80 working days

Medical Devices/IVDs – Actual Timeline (based on experience):

Class A – 1 to 2 months

Class B/C – 3 to 4 months

Class D – 4 to 6 months

SPECIAL REQUIREMENTS:

On-site Audit: Not required.

Local Tests/Permit: May be required for some devices such as disposable sterile syringes, HIV test products, medical devices that contain/transmit radiation, medical devices that transmit radiofrequency/Bluetooth.

Local Clinical Evaluation or Studies: Not required.

LOCAL FEES (New Application):

Medical Devices & In-vitro Diagnostics (IVDs)

Class A: USD $100

Class B/C: USD $200

Class D: USD $333

LOCAL FEELS (Manufacturer): No manufacturer registration is required. The local authorized representative, however, must be an establishment that holds a valid Medical Device Distributor License (MDDL) and implements a Good Distribution Practice of Medical Device (GDPMD).

LICENSE VALIDITY: Maximum 5 years (depending on the validity of authorization letter issued by the foreign manufacturer).

LICENSE TRANSFER: License transfer is possible but new registration is required.

AUTHORIZED REPRESENTATIVE: A solely local authorized representative should be appointed by an overseas manufacturer through official Letter of Authorization (LoA).

Last updated on November 5, 2020